Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mr John Keating
ORCID ID
Contact details
Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
Edinburgh
EH16 4SU
United Kingdom
+44 (0)131 242 3436
johnkeating@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/24/03
Study information
Scientific title
Acronym
STARS
Study hypothesis
In a prospective randomised multicentre trial we will evaluate the management of displaced subcapital fractures in fit elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. The trial will be conducted under the auspices of the Scottish Orthopaedic Trial Network, which involves the four university orthopaedic centres and associated district general hospitals. Patients will be randomised to one of three treatment groups and will be followed up for a minimum of two years.
Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2000 to 31/08/2002.
Ethics approval
Not provided at time of registration.
Study design
Prospective randomised multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, occupational diseases, poisoning: Musculoskeletal injury
Intervention
There are three treatment options:
1. One method of mending the break is with a type of screw, sometimes with a plate on its side; the two parts of the bone are joined together, and no bone is replaced.
2. A second method using a hip replacement. The ball at the end of the femur bone is replaced by an artificial 'ball' which is fixed into the top of the rest of the femur bone; the socket is not replaced.
3. The third method is also a type of hip replacement. Like the second method, the ball of the femur is replaced, but the socket in the hip bone is also replaced.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Clinical outcome will include perioperative mortality and reoperation. Functional outcomes will be assessed using a hip rating questionnaire and the EuroQoL functional outcome questionnaire. A cost-effectiveness and cost utility analysis will be integrated into the study protocol.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/06/1996
Overall trial end date
31/08/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
298
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1996
Recruitment end date
31/08/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Orthopaedics
Edinburgh
EH16 4SU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Keating JF, Grant A, Masson M, Scott NW, Forbes JF, Displaced intracapsular hip fractures in fit, older people: a randomised comparison of reduction and fixation, bipolar hemiarthroplasty and total hip arthroplasty., Health Technol Assess, 2005, 9, 41, iii-iv, ix-x, 1-65.